Healthy Skepticism Library item: 1261

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Retsinas G.
The Marketing of a Superbaby Formula
The New York Times 2003 Jun 1
http://www.nytimes.com/2003/06/01/business/the-marketing-of-a-superbaby-formula.html

Full text:

Parents who hire tutors to make sure their 3-year-olds can beat out the competition for the best nursery schools are now being told that the time to give their offspring an academic edge comes far, far earlier.

New baby formulas supplemented with fatty acids are being promoted as a way to bolster I.Q. and improve eyesight in infants. For formula manufacturers, including Abbott Laboratories, Bristol-Myers Squibb and Wyeth, the additives have become the latest weapon in the $3 billion market in the United States, where competition has grown more intense as mothers reject formula in favor of breast-feeding.

The problem, say some parents and doctors, is that the additives may not do what the companies say they do, although their use could cost parents an additional $200 a year for formula. The Food and Drug Administration, which oversees the composition of formula, last year allowed inclusion of the acids, after a five-year review. But the F.D.A. did not accept the argument of formula makers that the additives provide great health benefits, calling the results of studies “mixed.” A major independent study ordered by the F.D.A. will not be released until September, and the American Academy of Pediatrics has not endorsed the new formulas because of what it calls their “unknown adverse effects.”

Nevertheless, many parents, persuaded by intense advertising campaigns, are choosing to buy the new products.

Although infant formula contains a complex mixture of more than two dozen vitamins and minerals, it is treated as a food product, not as a drug, and its manufacturers decide what claims can be made on the label.

While makers of baby formula have long promoted the benefits of their products, their marketing of the formula with the fatty acids DHA and ARA is more aggressive, parents and pediatricians say. One magazine advertisement suggests that a baby will develop “the mind of a scientist” by drinking the formula. The label of another calls the acids “important building blocks.” Many hospitals are receiving free samples of the new formulas, which are given to parents after their babies are born.

Summer Benoit, a 28-year-old new mother in Wyoming, Minn., chose to switch to formula after breast-feeding her first child, Andrew, for two months because she was returning to work. To her, the formula cans looked vaguely alike and had similar names. She based her choice on the fact that coupons in a magazine offered a $10 discount for Enfamil Lipil, complete with a claim that it was the next-best thing to breast milk.

“So, obviously, you hear that, and being a new mom, you want whatever that is, and you try it,” said Ms. Benoit, a customer service representative for a water filter company near Minneapolis. She had to switch to a different product, however, because Andrew didn’t do well with the formula with additives.

The F.D.A. says it has not received any consumer complaints about the new additives in formulas, which it added to its list of “generally regarded as safe” ingredients, without commenting on their effectiveness. But it has asked the makers of the new formulas to do “rigorous post-market surveillance because there is no history of their use in the U.S.” The additives have been used in formulas sold abroad since 1996.

Ross Products, the Abbott subsidiary that produces the Isomil and Similac brands, and Mead Johnson Nutritionals, the Bristol-Myers subsidiary that makes Enfamil, are the largest companies in the business. Both have completed dozens of clinical trials that have showed short-term benefits among infants who were fed formulas with the additives. One of the longest studies tracked infants from birth to 39 months and found that the I.Q.‘s of children who used the enhanced formula were equivalent to those of children who were fed with breast milk, which is widely considered to be the best nourishment for newborns. They were not compared with infants who were fed formula not enhanced with the fatty acids.

Studies have varied in their approaches. For example, research at the University of Kansas, financed by the industry, found that infants who had taken formula with the fatty acids looked at pictures of faces for slightly shorter times than did infants who had not had the enhanced formula. That suggested that the cognitive development of the first group was more advanced, the researchers said.

A report last year by the American Council of Science and Health, a consumer education group in New York, reviewed nearly two dozen studies on the topic and found that about a third showed no difference in infants who took the DHA-supplemented formulas versus those who did not, while the other two-thirds showed benefits for the babies.

Some critics say the lack of long-term, independent studies is significant.

The Institute of Medicine, a part of the National Academy of Science, a nonprofit research organization that advises the federal government on scientific matters, has been studying the additives for two years and is expected to release its findings in the fall.

The F.D.A. requested the institute’s study, and an F.D.A. spokeswoman said that if any problems happened to emerge, the F.D.A. could use its authority to recall the products. But because formula is regulated as a food product, not as a drug, the F.D.A. does not control what claims the manufacturers can make or whether the products live up to those representations.

T’S unproven or uncertain that those ingredients provide an extra benefit,” said Dr. Cheston M. Berlin Jr., a pediatrician in Hershey, Pa., and a member of the Institute of Medicine panel. “I wouldn’t use the word `misleading,’ but they are certainly presented in a fashion that if they don’t do it, they aren’t doing a favor for their kids,” he said of the advertising aimed at parents.

In a recent issue of American Baby magazine, for example, three full-page color ads were devoted to the enhanced formulas. Each product’s ad suggested that a baby’s brain development would improve with the additives. The fine print for one product, Similac Advance, did note that another Similac formula without the additives would also support brain and eye development.

The two acids in the additives have long been linked to health benefits beyond the world of babies. DHA, or docosahexaenoic acid, for example, which is found in fish oil, is thought to help reduce the risk of heart attacks, according to the DHA Information Center at Rockefeller University in New York. ARA, arachidonic acid, also a fatty acid, is found in meat, eggs and milk and is believed by some to improve brain development.

After Mead Johnson, based in Evansville, Ind., rolled out Enfamil Lipil last year, Ross Products, based in Columbus, Ohio, followed with Isomil Advance and Similac Advance — products that contain the supplements but in lesser amounts than in Enfamil. At the time, Ross officials said they were not convinced of the scientific benefit but were introducing the products to give customers more choice.

Now Ross is actively promoting the brands with the additives, especially to pediatricians, whom the formula companies regard as pivotal in reaching parents. “We have sales reps who try to convince them that Similac Advance is a good thing to do,” said Rock Marasco, vice president of Ross Products.

Mr. Marasco, like other executives in the formula business, said his company had no plans to stop making the nonadditive formulas because many consumers might still be attached to those brands.

Ross has about a third of the infant-formula market, second to Mead, which has more than half. The other major players are the Swiss giant Nestlé and Wyeth, based in Madison, N.J., which makes Wal-Mart’s Parent’s Choice formulas as well as America’s Store Brand, which is sold at stores like Kmart and Target and wrapped in their own labels. Parent’s Choice also offers the additives with one of its brands. Nestlé does not make a formula enhanced with DHA-ARA.

Dr. Berlin said parents who have received manufacturers’ coupons and brochures promoting the additive-enhanced formulas have asked him if they are better. He tells them to buy cheaper nonadditive generic brands because they provide just as much benefit.

The manufacturers justify the added cost by citing both past and current clinical trials and the fact that only one company makes the forms of DHA and ARA used in infant formula.

Martek Biosciences, a biotechnology company in Columbia, Md., came up with its DHA-ARA blend from algae and fungi. Last year, it acquired OmegaTech, a Colorado concern that was also producing DHA and which had financed the Kansas study.

Martek, whose DHA-ARA oils are used in formulas around the world, raised $83 million in a stock offering in April, and its stock has doubled in the last six months. It earned more than $28 million on the sale of additives for infant formula in the United States last year, and plans to add the nutritional supplements to other products, including those marketed to pregnant women.

Henry Linsert Jr., Martek’s chief executive, said global sales should reach $100 million this year, half from companies in the United States.

ORMULA makers would not discuss sales details, but all the companies that have added products with the fatty acids have had increases in overall sales. They have reached parents through hospitals, which often include the product with free-sample packages that also contain disposable diapers, discount coupons and magazines. The companies hope that new parents will stick with their brand after trying it during their babies’ first days.

For the manufacturers, the advertising is a way to increase sales in a market where competing products are hard to tell apart. Todd N. Lebor, an analyst at Morningstar Inc. in Chicago, said: “It’s like the Pampers business or any of these demographic-based businesses that just sort of grow with population. If you’re not taking market share, you’re probably not growing.”

Dr. Jennifer Thomas, a pediatrician in Racine, Wis., said that “new parents are being reached in a very vulnerable time in their lives.”

While Dr. Thomas says she advises parents that formula is not as good as breast milk, many hospitals encourage the use of formula through their gift bags. New parents at All Saints Medical Center — the largest hospital in Racine, with about 1,800 deliveries annually — are given the DHA-ARA brands of Enfamil and Similac, which are provided free by the manufacturers.

Despite opposition from the American Academy of Pediatrics, most hospitals accept the free formula, which they use in their own nurseries. Some accept it on the assumption that parents will ask for the premium brands anyway, having seen them in advertising.

Some hospitals resist taking free formula, but they are few. One is the tiny South County Hospital in Wakefield, R.I., which spends about $200 a month on formula and has stopped letting manufacturers provide goody bags, posters and other marketing materials.

About half the formula sold in the United States is bought through the Women, Infants and Children program, a federal grant program that operates in each state and provides food and nutrition counseling for low-income mothers. In a few states, the programs accept DHA-ARA formulas; parents can choose cheaper products in those states, but if they start in hospitals with the DHA-ARA brands, they may be reluctant to change. The WIC program in California allows only the DHA-ARA formulas for premature infants.

Other states have chosen not to allow the new formulas through WIC, citing the extra cost. In North Dakota, where the WIC program feeds about 3,300 infants annually, administrators have decided to renew a contract with Nestlé for its Carnation brand.

Colleen Pearce, the state’s program director, said she had considered the new formulas but decided that studies of them were “a mixed bag.”

“If it really isn’t that big of a deal in terms of providing a beneficial effect for normal healthy infants, why would we want to go that route and face the added cost?” she said.

OSS PRODUCTS, which has surveyed breast-feeding annually for nearly 50 years, found that nearly 70 percent of mothers initially breast-fed their children in 2001, the highest rate to date. But that percentage is cut in half by the time the baby reaches six months, when many parents begin using formula.

In Minnesota, Ms. Benoit breast-fed Andrew for his first two months before switching to formula. But she said she remained confused over whether she erred in taking her child off of the enhanced formula. Her husband, Dustin, has been in Iraq with his Army Reserve unit since February, leaving her to make the child-rearing decisions alone.

“When you have new mothers and people who really don’t know anything about formula, everybody hears it’s the next-best thing,” she said, “and that’s what we’re going to buy.”